Learn how to start eConsent process in the Climedo system and what need to be considered.
⭐ Please note: If you only see the three columns ‘Consent type’, ‘Consent status’ or ‘Consent name’ in the Subject Overview, this means that you only have ‘Read rights’ and cannot carry out the processes described below. |
1. Assign the eConsent signee upon subject enrolment
Assign the consent signee on the subject enrolment screen. You will only be able to select collaborators with "sign" role rights in the dropdown.
⚠️ To successfully start the eConsent signing process, it is necessary to add the First name and Last name of the subject (upon enrolment). |
2. Start the eConsent signing process
Triggering/sending of the signature request to subject and doctor via click on "Start eConsent" in the: | |
eCRF or | ![]() |
Subject Profile | ![]() |
If there are multiple eConsent forms available for this subject, please make sure to select the suitable one from the dropdown list (e.g. based on the subject's language) and proceed with the action.
3. Cancel a signature process
If you triggered a signature process, for example, by accident or the patients decided not to drop out of the study, it is possible to cancel the signature request. Thereby, the form sent to the doctor and patient via email will become invalid and can no longer be signed. The option to cancel a signature request is visible in the eCRF or subject profile of the subject once the signature request has been sent out.
4. Re-send signature request (after cancellation or expiration of the request)
If you wish to re-send a signature request, e.g. after the initial signature request was cancelled or the process expired, you will automatically see the "Re-start eConsent" button in the eCRF and subject profile. Upon clicking on this button, a new eConsent email will be sent out to both the patient and the doctor.
5. Re-Consent
If an eConsent form has already been signed successfully by all parties, but there is a need to re-consent for a subject (e.g. due to a protocol amendment), it is possible to trigger the eConsent signature process once again by clicking on "eConsent signed, re-consent" and choosing the respective form. This button is shown for all subjects with a completed eConsent signature process.
6. Tracking the eConsent status in the subject overview
There are several columns that can be visualised in the subject overview that provide more information about a subject's eConsent.
![]() | Track the status of the signature request status for each subject. The following statuses can be tracked:
|
![]() | The Consent name indicates which eConsent form has been triggered (and signed) for the respective subject. |
![]() | The Consent signee was selected at the time of a subject's enrolment and represents the party, in addition to the patient, to complete the signature process. |
![]() | Timestamp of when the eConsent signature request was sent / when the eConsent was triggered. |
![]() | Timestamp of when the eConsent status (as indicated in 2) was updated. |
7. Updating the eConsent signee
To update an eConsent signee, e.g. if they have been incorrectly assigned or are no longer authorised to sign, the following steps are required:
- Go to the subject overview
- Select the subject(s) for which you want to update the signee
- Click on the "Actions" button
- Select "Update consent signee"
- Select the new signee from the dropdown in the dropdown
Please note: You can only update the signee when there is no eConsent signature process in progress for this subject. If you wish to change the signee for an eConsent with the status "signing initiated", you need to first cancel the process manually in the subject profile or the eCRF (see point 3).
8. Automated consent document upload to the subject profile
Once all parties have signed the eConsent and the status is set to "signed", the consent document will be automatically uploaded to the "File uploads" section of the respective subjects profile. The document can be viewed and downloaded by double-clicking on the file by any user who has the role right to read subject files.
9. Signing the Consent document via YouSign®️ (Available in several languages)
Once the signature request has been triggered, all signees will automatically receive an invitation email from our partner YouSign®️ to sign the consent document.
After opening the link to start the signing process, the signees will at first have to fill in some pre-defined information that is required for the consent form. In this case, it is the first name, date and time of signature, phone number etc. which will then be added to the document.
As a second step, the signees will be able to read the entire document and once finished, they can click the sign button to officially sign the document.
Depending on the chosen signature type, a two-factor authentication or a video ident process must be completed. In the below case of a simple signature, the signee simply needs to swipe right and his/her signature is automatically added.
Hybrid Studies
Enrollment
If your study is using a hybrid consent set-up (eConsent and Paper Consent), you have the option of specifying whether the subject signs the informed consent digitally or on paper when enrolling the subject.
Subject overview
In the subject overview you will find two relevant columns: "Consent Type" and "Consent Status". The "Consent type" column indicates whether the subject has been selected to complete the consent digitally or on paper. You can manually adjust the consent status for paper-based consents. The eConsent status is automatically adjusted by the system.
The following statuses are available for paper-based consent. These are displayed in a pop-up window when clicking on the status of the consent of the respective subject. | ![]() |
Change consent type
You also have the option to change the consent type for a subject. To do this, select the respective subject from the Subject Overview, click on "Actions", then select "Update consent type". Please make sure to change the status of the Paper consent back to "not started" since an already started consent workflow cannot be changed.
A new pop-up window opens. Here you can select and save the new consent type. In case of a change from eConsent to paper-based Consent, the button to start the eConsent process for a subject disappear from the eCRF and subject profile. | ![]() |
⚠️ Please check whether a Consent signee has been selected for this subject. If no signee is entered, no eConsent process can be started. Read more about this topic in section "7. Updating the eConsent signee" above. |
✉️ Still have questions? Please contact your study coordinator. |
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